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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION CORPORATION AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8805
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2017
Event Type  malfunction  
Event Description
Staff was responding to a cardiac arrest. Airlife adult resus bag was attached to the code cart in sealed clear plastic bag. The adult resus bag was attached to a pediatric sized mask. Unable to use on adult patient.
 
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Brand NameAIRLIFE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION CORPORATION
75 north fairway drive
vernon hills IL 60061
MDR Report Key6584073
MDR Text Key75737999
Report Number6584073
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8805
Device Catalogue Number2K8005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer05/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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